BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3222361 · Received July 12, 2013

    Report

    Report Number
    2183996-2013-01276
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    September 6, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE RETURNED HEAD SET AND TRANSFER SET WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. ADDITIONALLY THE DIMENSIONAL ACCURACY OF THE LUER WAS TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE LEVEL HAS BEEN ELEVATED INTO THE MID 300'S MG/DL DURING THE PAST FOUR DAYS. HER NORMAL FASTING BLOOD GLUCOSE LEVEL RANGE IS 70-80 MG/DL AND TWO HOURS AFTER A MEAL 140-150 MG/DL. ON (B)(6) 2013, SHE WOKE UP AND HER BLOOD GLUCOSE LEVEL WAS 55 MG/DL AT 8:28 AM AND THE PREVIOUS MORNING IT WAS 270 MG/DL. SHE STATED THAT THE PAST FOUR INFUSION SETS HAVE NOT WORKED. SHE HAS SUCCESSFULLY BEN ABLE TO CORRECT HER ELEVATED BLOOD GLUCOSE LEVELS VIA ADDITIONAL BOLUSES WITH THE INFUSION DEVICE. SHE STATED THAT SHE THINKS THE INFUSION SETS ARE BLOCKED OR LEAKING AT THE LUER LOCK CONNECTION. WHEN SHE UNSCREWS HER LUER IT SEEMS TO BE WET AND SHE CAN SMELL THE INSULIN. ON (B)(6) 2013 AT 11:30 AM HER BLOOD GLUCOSE LEVEL WAS 323 MG/DL AND SHE WAS ABLE TO CORRECT WITH THE INFUSION DEVICE. AT 9:00 PM IT WAS BACK UP TO 338 MG/DL. THE PATIENT SWITCHED TO HER BACKUP DEVICE AND HER BLOOD GLUCOSE LEVELS CONTINUED TO BE ELEVATED. SHE HAS BEEN UNDER ADDITIONAL STRESS LATELY AND STATED THAT THIS COULD BE A CONTRIBUTING FACTOR TO HER ELEVATED LEVELS. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS, INSULIN CARTRIDGE, AND ADAPTER WERE REPLACED AND WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324014 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC NA 5019857

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR ASPIRIN| AVIVA COMBO| CINNAMON| LISINOPRIL| PAXIL| LOVASTATIN| NOVOLOG U100 INSULIN| VITAMIN D3